Pharma Manufacturing

India’s top 20 pharmaceutical companies are increasing capital expenditures by 40 percent to take advantage of market opportunities to come, says a report from CRISIL, a global analytical company providing ratings, research, risk and policy advisory services. The article, which appeared on The Economic Times of India website, attributes the CapEx increase in India to the fact that the country’s “drug makers are expected to pay greater attention to regulated markets, especially the U.S. market, and to take advantage of substantial patent expiries expected in the medium term, as well as an ever-increasing demand for generics.”
There’s been no shortage of criticism of India’s pharmaceutical industry and its drug-quality lapses. A…

Vetter, well-known CMO and experienced aseptic parenteral processor, recently achieved Authorized Economic Operator Full (AEO-F) status from the European Union. Internationally accepted, AEO-F certification affirms that Vetter maintains the highest reliability, solvency and safety standards in international pharmaceutical trade. The AEO-F certificate is currently accepted by the U.S. and Japan, the EU Member States, Switzerland, Norway and China.
According to Vetter, the certification facilitates the import of drugs in third countries and confirms the quality, reliability and performance of its entire supply chain. Equipped with the AEO-F, customs procedures associated with consignments will be simplified and accelerated, “all of which…

Pharma can take inspiration from industries with mature quality systems and advanced quality capabilities

Quality has a special meaning in pharmaceuticals, where production or distribution errors can jeopardize human life. But other industries face similar challenges, and some have developed sophisticated quality systems. As pharmaceutical companies look for ways to improve their quality practices and performance, they can take ideas from these quality leaders and adapt them for pharma.
Quality can be defined in various ways, from “fitness for purpose” to “meeting customer expectations” to predictability in statistical terms. Each industry understands quality differently, and priorities depend on the specifics of products and markets. In the automotive industry, for instance, companies generally define quality as the ability to meet…

For pharma operations, the question isn’t “When to go digital?” It’s “How fast can we get there?”

Industry after roiled industry is being transformed as digital innovation becomes the mother of new methods, efficiencies - and businesses.
In pharmaceuticals, the first wave of the digital revolution has largely been focused on using technology platforms and data analytics to better understand customers, increasing patient engagement and developing new go-to-market approaches.
Change in pharmaceutical operations has proceeded more cautiously, partly because in a supply chain already complicated by so many country-by-country regulations, rising quality-control scrutiny, more complex product portfolios, increasingly competitive pricing, an ever-widening universe of supply chain partners and the threat of counterfeiting, the hurdles to…

To combat potentially unsafe counterfeit drugs and product diversion, the FDA passed the Drug Supply Chain Security Act (DSCSA) in 2013, creating federally mandated requirements for traceability of pharmaceutical products. Fast approaching is a November 2017 DSCSA compliance deadline with additional serialization requirements. While the disruption to existing manufacturing and distribution processes will be significant, it is vital to impose supply chain visibility to prevent diversion and counterfeit products from reaching consumers.
PMMI sat down with Steve Peterson, product manager at the Peterson Group and Mario Simard, senior product line manager at Optel Vision to discuss what strategies pharmaceutical manufacturers should…

Make sure the pressure transmitters used in your CIP/SIP application are designed for that service.

In a perfect world, all the instruments used for process control would maintain their specified accuracy under any and all conditions short of damage, and maintain the same accuracy for the same process variable value regardless of what happens between measurements.
Figure 1. Repeated exposure to the high temperatures involved in CIP/SIP can cause a pressure transmitter not specifically designed for such conditions to drift out of calibration.
In the real world, instruments’ characteristics change, even if only slightly, as their operating conditions change. In sanitary processes subjected to clean-in-place (CIP) and sterilization-in-place or steam-in-place (SIP), instruments must withstand rapid changes in temperature and pressure…

The FDA has approved -- for the first time in history -- a manufacturer’s production method change from “batch” to continuous manufacturing.

Click image to enlarge
Yesterday, Lawrence Yu, FDA’s Deputy Director, wrote a blog post about a landmark event for continuous manufacturing.
The FDA has approved -- for the first time in history -- a manufacturer’s production method change from “batch” to continuous manufacturing.
This new approval is for manufacturing Janssen Products' medication for the treatment of HIV-1 infection, Prezista (darunavir), at Janssen's Gurabo, Puerto Rico, plant.
While even the FDA admits the transition from batch to continuous is "not easy," the agency is encouraged by the fact that it is seeing a growing number of manufacturers working towards building continuous manufacturing into their processes.
For Janssen, the decision to introduce CM…

The PAT (draft) Guidance was introduced in 2002, finalized in 2004, and is still largely ignored as an option by a huge number of pharma companies. Why? That is a simple question with a multi-faceted answer.
Having said that, let’s look at the money involved. PAT will cost money and time and, as the old saw goes, “time is money.” Having the money and allocating it are two different matters. While the industry still makes huge profits, it also still uses antiquated accounting and payment practices. Add to that it also considers cross-training, instrumentation/short courses and conferences as “overhead” and not necessary for this quarter’s profit.
Also, largely still in place, is the “justification” of capital spending. At…

The next decade of drug development will be based upon new and more effective means of data mining and data analytics

The pharma landscape is evolving as rapidly as the speed of technology. The industry that former FDA Commissioner Dr. McClellan admonished in 2003 with, “You need to improve!”1 has taken those words to heart to embrace innovation and technology as never before. Whether motivated by the FDA’s shift toward a scientific, data-driven definition for quality or a need to innovate to survive and be competitive in the new world marketplace, there is no doubt the push for greater understanding has resulted in a renewed emphasis on the ability to acquire, verify and leverage the power of data.
THREE DRIVERS FOR CHANGEEvery market sector needs a push sometimes to adapt and evolve. The regulated life sciences are one of the most conservative…

New xCELLigence RTCA CardioECR is the first platform for simultaneous measurement of Cardiomyocyte Contractility and Electrophysiology

Responding to the need for more predictive preclinical assays for cardiac liability, ACEA Biosciences introduced a “ground-breaking” device the company describes as “next generation.” Designated the xCELLigence RTCA CardioECR System, it is…

Are the risks of leveraging this new technology outweighing the benefits for drug makers?

Since 3D printing emerged, the technology has been used to create everything from construction materials and automobile parts to cheeseburgers and sneakers.3D printing has enormous potential across industries, and one of the most transformative applications has been in the medical field. The technology has been used to create prosthetic limbs, body tissue, dental restorations and more. In fact, as of December 2015 the FDA had cleared more than 85 3D-printed medical devices.But one of the latest medical applications – 3D printed pharmaceuticals – has called into question whether the risks of leveraging this new technology outweigh the benefits for drug makers.Manufacturing pharmaceuticals has been part of the 3D printing discussion for…

In the already diverse field of biopharmaceuticals, chemistry manufacturing and control (CMC) is about to get more complex. New formats and formulations will change CMC requirements, dictated by the need to characterize products of increased complexity and the expectation of authorities that companies will keep pace with the latest technologies so as to minimize quality risks.The potential implied changes required for an effective CMC include: more extensive information handoffs, greater cross-functional cooperation and a greater focus on relationships with regulatory agencies. These trends will demand a rethinking of the CMC setup and an appraisal of its capabilities based on a company’s product pipeline.Overarching…

In the already diverse field of biopharmaceuticals, chemistry manufacturing and control (CMC) is about to get more complex. New formats and formulations will change CMC requirements, dictated by the need to characterize products of increased complexity and the expectation of authorities that companies will keep pace with the latest technologies so as to minimize quality risks.The potential implied changes required for an effective CMC include: more extensive information handoffs, greater cross-functional cooperation and a greater focus on relationships with regulatory agencies. These trends will demand a rethinking of the CMC setup and an appraisal of its capabilities based on a company’s product pipeline.Overarching…

Converging factors are pushing drugmakers to adopt a more modern approach, and technology-enabled Product Lifecycle Management will be the key

At the product level, pharmaceutical companies are constant innovators, perpetually unveiling new and more powerful treatments for a growing range of ailments. When it comes to manufacturing, however, drugmakers are notorious for lagging other industries. (Just last year, The Wall Street Journal described pharmaceutical manufacturing processes as “dating to the days of the steam engine.”)
More specifically, pharmaceutical manufacturers have not been able to realize the benefits of Product Lifecycle Management (PLM) technology, unlike their counterparts in the discrete manufacturing world. There, PLM is a technology-enabled discipline that has connected every step in the product lifecycle, enabling radical improvements in product…

In order for biopharma companies to move quickly and adaptively enough, an outstanding project management process is critical

The global biopharmaceutical market is expected to grow at a compound annual growth rate (CAGR) of 9.4% from 2014 to 2020, reaching $278 billion in revenue by the end of this six-year period. Growth is being driven by numerous factors: such as aging populations in most of the Western world and an increased prevalence of chronic disease. However, likely the most important contributor to growth is biopharmaceutical drugs’ superior effectiveness in treating many disease states, including treating conditions for which there were previously few effective drug treatment options available.
Given the growth of the biopharmaceutical segment, and biopharmaceuticals’ ability to more precisely treat many disease states, the industry needs to…

Converging factors are pushing drugmakers to adopt a more modern approach, and technology-enabled Product Lifecycle Management will be the key

At the product level, pharmaceutical companies are constant innovators, perpetually unveiling new and more powerful treatments for a growing range of ailments. When it comes to manufacturing, however, drugmakers are notorious for lagging other industries. (Just last year, The Wall Street Journal described pharmaceutical manufacturing processes as “dating to the days of the steam engine.”)
More specifically, pharmaceutical manufacturers have not been able to realize the benefits of Product Lifecycle Management (PLM) technology, unlike their counterparts in the discrete manufacturing world. There, PLM is a technology-enabled discipline that has connected every step in the product lifecycle, enabling radical improvements in product…

Converging factors are pushing drugmakers to adopt a more modern approach, and technology-enabled Product Lifecycle Management will be the key

At the product level, pharmaceutical companies are constant innovators, perpetually unveiling new and more powerful treatments for a growing range of ailments. When it comes to manufacturing, however, drugmakers are notorious for lagging other industries. (Just last year, The Wall Street Journal described pharmaceutical manufacturing processes as “dating to the days of the steam engine.”)
More specifically, pharmaceutical manufacturers have not been able to realize the benefits of Product Lifecycle Management (PLM) technology, unlike their counterparts in the discrete manufacturing world. There, PLM is a technology-enabled discipline that has connected every step in the product lifecycle, enabling radical improvements in product…

Converging factors are pushing drugmakers to adopt a more modern approach, and technology-enabled Product Lifecycle Management will be the key

At the product level, pharmaceutical companies are constant innovators, perpetually unveiling new and more powerful treatments for a growing range of ailments. When it comes to manufacturing, however, drugmakers are notorious for lagging other industries. (Just last year, The Wall Street Journal described pharmaceutical manufacturing processes as “dating to the days of the steam engine.”)
More specifically, pharmaceutical manufacturers have not been able to realize the benefits of Product Lifecycle Management (PLM) technology, unlike their counterparts in the discrete manufacturing world. There, PLM is a technology-enabled discipline that has connected every step in the product lifecycle, enabling radical improvements in product…

Validation, calibration and qualification are extremely critical in pharmaceutical processes. Understanding them is necessary in order to meet cGMP guidelines.

Pharmaceutical facilities consist of various processes, each of which must be accurate to ensure that the end product is of high quality. While validation is concerned mainly with processes, it is referred to as a qualification when the same approach is applied to a machine or equipment instead of a process.
Why is Validation Needed?Validation is a systematic approach where it is confirmed that any process in a pharmaceutical facility will operate within the specified parameters whenever required. This is achieved by collecting and analyzing data. Validation is done to assure that the processes will produce consistent and repeatable results within the predetermined specifications.
Validation is needed as it verifies whether the quality…

Last month I walked the show floor at Pharma EXPO, executing my usual tradeshow-technology-trend spotting. It was difficult to advance more than 10 feet without hearing or reading the world “serialization.” I’m fairly certain serialization could have had its own hall at McCormick Place.
And perhaps the attention is warranted given the timing. The November 2017 DSCSA compliance deadline, after all, is a federally mandated requirement. The DSCSA will require all prescription drugs in the U.S. to have unique serial numbers to enable track and trace. This marks the first time that many pharma manufacturers and supply chain partners will have to implement serialization and manage serialized product inventory, though many are ahead of the…

The U.S. FDA, under fire for its drug approval backlog, says it has over 700 job vacanies at CDER.

The U.S. FDA, under fire for its drug approval backlog, says it has over 700 job vacanies at its Center for Drug Evaluation and Research (CDER).
At a recent industry event, Janet Woodcock said that the agency is struggling to hire and retain staff because pharmaceutical companies are offering employees much higher salaries.
CDER had 711 openings out of 5,525 positions at the end of September, said an FDA spokewoman.
Aside from salary, the speed in which the agency goes through the hiring process is a challenge. “A young person with a family can’t wait four months for us to get through some of the federal hiring process. So if they have something else that’s more . . . expedient, they will take that,” said Peter Marks,…

Validation, calibration and qualification are extremely critical in pharmaceutical processes. Understanding them is necessary in order to meet cGMP guidelines.

Pharmaceutical facilities consist of various processes, each of which must be accurate to ensure that the end product is of high quality. While validation is concerned mainly with processes, it is referred to as a qualification when the same approach is applied to a machine or equipment instead of a process.
Why is Validation Needed?Validation is a systematic approach where it is confirmed that any process in a pharmaceutical facility will operate within the specified parameters whenever required. This is achieved by collecting and analyzing data. Validation is done to assure that the processes will produce consistent and repeatable results within the predetermined specifications.
Validation is needed as it verifies whether the quality…

Converging factors are pushing drugmakers to adopt a more modern approach, and technology-enabled Product Lifecycle Management will be the key

At the product level, pharmaceutical companies are constant innovators, perpetually unveiling new and more powerful treatments for a growing range of ailments. When it comes to manufacturing, however, drugmakers are notorious for lagging other industries. (Just last year, The Wall Street Journal described pharmaceutical manufacturing processes as “dating to the days of the steam engine.”)
More specifically, pharmaceutical manufacturers have not been able to realize the benefits of Product Lifecycle Management (PLM) technology, unlike their counterparts in the discrete manufacturing world. There, PLM is a technology-enabled discipline that has connected every step in the product lifecycle, enabling radical improvements in product…

As pharma companies expand, they are looking more and more to biologics for their next potential blockbusters. However, this class of product — ranging from well-established large molecule drugs to truly novel therapies — poses major challenges because of its scientific complexity and sophisticated development requirements.Furthermore, expanding the drug pipeline isn’t the only growth strategy most companies are pursuing. They are also planning to expand geographically and expect to face various risks doing so, including unfamiliar regulatory environments, shifts in pricing and changes in customers’ ability to pay.
All this means that risk management is rising in pharma executives’ agendas. To manage risks, companies are…

For pharma operations, the question isn’t “When to go digital?” It’s “How fast can we get there?”

Industry after roiled industry is being transformed as digital innovation becomes the mother of new methods, efficiencies - and businesses.
In pharmaceuticals, the first wave of the digital revolution has largely been focused on using technology platforms and data analytics to better understand customers, increasing patient engagement and developing new go-to-market approaches.
Change in pharmaceutical operations has proceeded more cautiously, partly because in a supply chain already complicated by so many country-by-country regulations, rising quality-control scrutiny, more complex product portfolios, increasingly competitive pricing, an ever-widening universe of supply chain partners and the threat of counterfeiting, the hurdles to…

Corrective actions are implemented to reduce future failures, but resources aren’t allocated to identify the root cause on a significant failure; This gap creates the opportunity to implement a RCFA program.

Your clean steam generator system stops and alarms. Production halts; operations quickly calls maintenance. Maintenance jumps into action and determines that the bearing seized in the feed water pump. A bearing order is expedited through procurement, maintenance efficiently makes the repair the next morning, and the production team runs tests before putting the system back into operation. Corrective actions are created to ensure that the bearing is stocked in the MRO storeroom, and to double frequency of the pump’s preventive maintenance. The senior leadership team is satisfied with the response and corrective actions, and praises the team for limiting the production delay to just 24 hours.
Does this scenario sound familiar? A critical…

Every cleanroom requires a carefully controlled environment maintained with Good Manufacturing Practices to prevent contamination

In 2012, a fungal meningitis outbreak in the United States was traced to a compounding pharmacy in the Northeast. The pharmacy distributed contaminated vials to medical facilities in 23 states. These were administered to more than 14,000 patients before anyone linked symptoms to the tainted medication.
By the time the source was isolated and the drug recalled, 48 people had died and 720 required treatment for persistent fungal infections. Investigators later discovered both procedural shortcuts and significant failures in cleaning and maintenance at the pharmacy.
This is not an isolated instance of inadequate cleanroom sanitation. The FDA maintains a well-populated list of inspections and citations conducted between 2006 and 2012 on its…

Pharma execs and facility managers are constantly exploring all possible ways to tighten their belts and bolster the company’s bottom line. A growing number are finding one path to savings runs through an often-overlooked area of their facility’s operations – its loading docks.

Pharmaceutical manufacturing is a highly competitive business, with product development, quality control, regulatory/compliance and even shareholder issues that are much more complex than in many other industries. Because of that, pharma execs and facility managers are constantly exploring all possible ways to tighten their belts and bolster the company’s bottom line. A growing number are finding one path to savings runs through an often-overlooked area of their facility’s operations – its loading docks.
When trailers are positioned at the dock being loaded or unloaded, gaps often exist between the trailer and the edges of the dock opening, through which expensive heating and cooling energy can escape, and unwanted contaminants…

Hyderabad-based API provider Neuland Labs sheds the stigma of Indian manufacturers by building stringent quality control into every process

Neuland Lab’s core business and operational expertise for more than 30 years has been the manufacturing of Active Pharmaceutical Ingredients (APIs) for the generic market as well as APIs for custom manufacturing. During that time, Neuland has become a reliable source in the pharmaceutical industry, boasting more than 400 DMFs worldwide, with 45 of those filed with the U.S. FDA.
One of the very first Indian contract manufacturers to be inspected by the U.S. FDA, back in 1997, Neuland now has two U.S. FDA- and EU GMP-compliant manufacturing facilities — one in Bonthapally and one in Pashamylaram (45,000m² and 38,000m², respectively), as well as a state-of-the-art R&D facility, with the collective ability to produce more than 75…

Sustainability lobby group Changing Markets has published a report that reveals the presence of lethal drug-resistant bacteria in water found near multiple production sites in India.

Sustainability lobby group Changing Markets has published a report that reveals the presence of lethal drug-resistant bacteria in water found near multiple production sites in India.
According to the report, analysis of water samples found high levels of drug-resistant bacteria at sites in three Indian cities: Hyderabad, New Delhi and Chennai.
Out of 34 sites tested, 16 were found to be harboring bacteria resistant to antibiotics. At four of the sites, resistance to three major classes of antibiotics was detected, including last resort antibiotics -- those used to treat infections that fail to respond to all other medicines.
The report called out Hyderabad-based Aurobindo Pharma as one of the worst offenders, saying the drugmaker is "a…

The new jobs will be in the sciences, clinical services and clinical technologies and pharmaceutical services

Ireland-based Almac Group, a CMO with U.S. headquarters in Souderton, Pennsylvania, announced it will invest $24.4 million to expand its Montgomery County, Pa., site and add 312 full-time jobs over the next three years. The company plans to expand its existing 240,000-square-foot Souderton facility and lease an additional 26,000 square feet in office space in nearby Lansdale.
The new jobs will be in the sciences, clinical services and clinical technologies and pharmaceutical services, the company said. They also plan to retain 1,110 current employees currently working there.
The Pennsylvania Department of Community and Economic Development offered funding that included a $1.56 million "first program" grant for new machine lines, computer…

North America and Europe will dominate the global biosimilars market as demand rises for these products

Like a phoenix, biosimilars rose from pharma’s ashes to revitalize an industry faced with the loss of patent exclusivity for several biologics. Now this global market is expected to reach $2 billion by 2018.1
While there are currently only four agents approved in the United States, more than 20 are approved in Europe.1 Development is accelerating, and according to some estimates, there are 56 biosimilar products in the pipeline, with 30 companies having active programs.1 In fact, according to the 2016 Nice Insight CMDO Outsourcing Survey, 50 percent of respondents are currently engaged in developing biosimilars.2
Biosimilars represent a significant opportunity for healthcare systems to deal with the rising cost of medications and access…

Hyderabad-based API provider Neuland Labs sheds the stigma of Indian manufacturers by building stringent quality control into every process

Neuland Lab’s core business and operational expertise for more than 30 years has been the manufacturing of Active Pharmaceutical Ingredients (APIs) for the generic market as well as APIs for custom manufacturing. During that time, Neuland has become a reliable source in the pharmaceutical industry, boasting more than 400 DMFs worldwide, with 45 of those filed with the U.S. FDA.
One of the very first Indian contract manufacturers to be inspected by the U.S. FDA, back in 1997, Neuland now has two U.S. FDA- and EU GMP-compliant manufacturing facilities — one in Bonthapally and one in Pashamylaram (45,000m² and 38,000m², respectively), as well as a state-of-the-art R&D facility, with the collective ability to produce more than 75…

North America and Europe will dominate the global biosimilars market as demand rises for these products

Like a phoenix, biosimilars rose from pharma’s ashes to revitalize an industry faced with the loss of patent exclusivity for several biologics. Now this global market is expected to reach $2 billion by 2018.1
While there are currently only four agents approved in the United States, more than 20 are approved in Europe.1 Development is accelerating, and according to some estimates, there are 56 biosimilar products in the pipeline, with 30 companies having active programs.1 In fact, according to the 2016 Nice Insight CMDO Outsourcing Survey, 50 percent of respondents are currently engaged in developing biosimilars.2
Biosimilars represent a significant opportunity for healthcare systems to deal with the rising cost of medications and access…

Just months after its $7.2B acquisition of Meda, Mylan is closing the company's U.S. headquarters in Somerset, NJ.

Just months after its $7.2B acquisition of Meda, Mylan is closing the company's U.S. headquarters in Somerset, NJ.
The closing, effective December 31 2016, will result in 94 layoffs.
Last February, Mylan agreed to buy Sweden’s Meda AB for $7.2 billion in cash and stock -- a price that represented a 92% premium -- and investors were not pleased. A large part of Mylan's attraction to the Meda deal involved acquiring Meda's European EpiPen sales, as well as its over-the-counter business. Meda turned down two previous buyout offers from Mylan in 2014. The acquisition of Meda also provides Mylan with entry into a number of new and attractive emerging markets.
Read the NJ.com release

State Officials Connect Specialty Compounding to Bacterial Outbreak

Texas Department of State Health Services told the Associated Press Tuesday that while state testing had identified the bacterium Rhodococcus equi in the products before, the most recent results showed a “genetic match” between the product and the blood samples of 15 of the 17 patients that had been sickened surrouding the August recall.

To date, Specialty Compounding's own testing and testing by the FDA have not found this particular bacterium.

In a recent company statement, Specialty Compounding said, “The pharmacy’s own testing similarly detected no Rhodococcus equi in its facility, in its products, or on its personnel.” “For this reason, it seems clear that Specialty Compounding was not the source of the infections.”

The FDA did find other types of bacteria, and stated in a November 15 release, "Based on our inspectional findings and the sample results, we do not believe Specialty Compounding should perform any sterile drug production at this time."

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